[Federal Register Volume 88, Number 234 (Thursday, December 7, 2023)]
[Rules and Regulations]
[Pages 85104-85109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26694]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-1036]


Schedules of Controlled Substances: Placement of Nine Specific 
Fentanyl-Related Substances in Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: With the issuance of this final rule, the Drug Enforcement 
Administration places nine fentanyl-related substances, as identified 
in this final rule, including their isomers, esters, ethers, salts, and 
salts of isomers, esters, and ethers whenever the existence of such 
isomers, esters, ethers, and salts is possible, in schedule I of the 
Controlled Substances Act. These nine fentanyl-related substances are 
currently listed in schedule I pursuant to a temporary scheduling 
order. This action makes permanent the imposition of the regulatory 
controls and administrative, civil, and criminal sanctions applicable 
to schedule I controlled substances on persons who handle (manufacture, 
distribute, import, export, engage in research, conduct instructional 
activities or chemical analysis with, or possess), or propose to handle 
these nine specific fentanyl-related controlled substances.

DATES: Effective date: December 7, 2023.

FOR FURTHER INFORMATION CONTACT: Dr. Terrence L. Boos, Drug and 
Chemical Evaluation Section, Diversion Control Division, Drug 
Enforcement Administration; Telephone: (571) 362-3249.

SUPPLEMENTARY INFORMATION: In this rule, the Drug Enforcement 
Administration (DEA) is permanently scheduling the following nine 
controlled substances including their isomers, esters, ethers, salts, 
and salts of isomers, esters, and ethers whenever the existence of such 
isomers, esters, ethers, and salts is possible, in schedule I of the 
Controlled Substances Act (CSA):
    <bullet> meta-fluorofentanyl (N-(3-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl)propionamide),
    <bullet> meta-fluoroisobutyryl fentanyl (N-(3-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl)isobutyramide),
    <bullet> para-methoxyfuranyl fentanyl (N-(4-methoxyphenyl)-N-(1-
phenethylpiperidin-4-yl)furan-2-carboxamide),
    <bullet> 3-furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-
phenylfuran-3-carboxamide),
    <bullet> 2',5'-dimethoxyfentanyl (N-(1-(2,5-
dimethoxyphenethyl)piperidin-4-yl)-N-phenylpropionamide),
    <bullet> isovaleryl fentanyl (3-methyl-N-(1-phenethylpiperidin-4-
yl)-N-phenylbutanamide),
    <bullet> ortho-fluorofuranyl fentanyl (N-(2-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl)furan-2-carboxamide),
    <bullet> alpha'-methyl butyryl fentanyl (2-methyl-N-(1-
phenethylpiperidin-4-yl)-N-phenylbutanamide), and
    <bullet> para-methylcyclopropyl fentanyl (N-(4-methylphenyl)-N-(1-
phenethylpiperidin-4-yl)cyclopropanecarboxamide).

Legal Authority

    The CSA provides that proceedings for the issuance, amendment, or 
repeal of the scheduling of any drug or other substance may be 
initiated by the Attorney General (1) on his own motion; (2) at the 
request of the Secretary of the Department of Health and Human Services 
(HHS); \1\ or (3) on the petition of any interested party.\2\ This 
action was initiated on the Attorney General's own motion, as delegated 
to the Administrator of the DEA (Administrator), and is supported by, 
inter alia, a recommendation from the Assistant Secretary for Health of 
HHS

[[Page 85105]]

(Assistant Secretary) and an evaluation of all relevant data by DEA. 
This action continues the imposition of the regulatory controls and 
administrative, civil, and criminal sanctions of schedule I controlled 
substances on any person who handles or proposes to handle meta-
fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl 
fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl 
fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, 
and para-methylcyclopropyl fentanyl.
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    \1\ As discussed in a memorandum of understanding entered into 
by the Food and Drug Administration (FDA) and the National Institute 
on Drug Abuse (NIDA), FDA acts as the lead agency within HHS in 
carrying out the Secretary's scheduling responsibilities under the 
CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The 
Secretary of HHS has delegated to the Assistant Secretary for Health 
of HHS the authority to make domestic drug scheduling 
recommendations. 58 FR 35460, July 1, 1993.
    \2\ 21 U.S.C. 811(a).
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Background

    On February 6, 2018, DEA published an order in the Federal Register 
(FR) (83 FR 5188) amending 21 CFR 1308.11(h), temporarily placing 
fentanyl-related substances, as defined in that order, in schedule I of 
the CSA based upon a finding that these substances pose an imminent 
hazard to the public safety and pursuant to the temporary scheduling 
provisions of 21 U.S.C. 811(h). The nine substances named in this final 
rule meet the existing definition of fentanyl-related substances, as 
they are not otherwise controlled in any other schedule (i.e., not 
included under another DEA Controlled Substance Code Number) and are 
structurally related to fentanyl by one or more of the five 
modifications listed under the definition. That temporary scheduling 
order was effective on the date of publication and was based on 
findings by the former Acting Administrator that the temporary 
scheduling of these substances was necessary to avoid an imminent 
hazard to the public safety pursuant to 21 U.S.C. 811(h)(1). Pursuant 
to 21 U.S.C. 811(h)(2), the temporary control of fentanyl-related 
substances, a class of substances as defined in the order, as well as 
these nine specific substances already covered by that order, was set 
to expire on February 6, 2020. However, on February 6, 2020, as 
explained in DEA's April 10, 2020, correcting amendment (85 FR 20155), 
Congress extended that expiration date until May 6, 2021, by enacting 
the Temporary Reauthorization and Study of the Emergency Scheduling of 
Fentanyl Analogues Act (Pub. L. 116-114, sec. 2, 134 Stat. 103). This 
temporary order was subsequently extended multiple times, most recently 
on December 29, 2022, through the Consolidated Appropriations Act, 
2023, which extended the order until December 31, 2024.
    Comment: One commenter stated that fentanyl and the list of related 
substances is a hazard due to the overdose deaths that have been 
occurring. This commenter also referenced the National Institute on 
Drug Abuse, stating that fentanyl-related overdoses have been 
increasing in the United States. Lastly, this commenter stated that 
permanently placing fentanyl and the list of related substances in 
schedule I would improve public health and allow for regulation of 
these substances.
    DEA Response: DEA appreciates the comments in support of this 
rulemaking. One clarification to note is that fentanyl remains a 
schedule II substance. This final rule only applies to the fentanyl-
related substances that are listed in this final order.
    Comment: One commenter stated the proposed rule would make it more 
difficult to produce and distribute these dangerous fentanyl-related 
substances, which would help combat the opioid epidemic in the United 
States. This commenter also referenced a news article by National 
Public Radio, stating that these nine fentanyl-related substances are 
not currently classified as controlled substances, making it easy to 
produce and distribute these substances without legal consequences. 
Lastly, this commenter recognized that this proposal could have 
significant impacts on the healthcare industry, such as increased 
oversight and regulation of fentanyl-related substances, which could 
prevent their misuse and abuse.
    DEA Response: DEA appreciates the comments in support of this 
rulemaking. One clarification to note based on the comment above is 
that, by temporary order on February 6, 2018, DEA placed these nine 
fentanyl-related substances under schedule I. 83 FR 5188. That 
temporary order defined a fentanyl-related substance to mean any 
substance not otherwise controlled in any schedule (i.e., not listed 
under another DEA Controlled Substance Code Number), and for which no 
exemption or approval is in effect under section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355), that is structurally 
related to fentanyl by one or more of five specified structural 
modifications. Therefore, these nine fentanyl-related substances are in 
fact already schedule I controlled substances.
    The final rule being issued today applies to nine fentanyl-related 
substances that were the subject of a February 6, 2018, temporary 
scheduling order. These nine substances will now be listed in 21 CFR 
1308.11(b), as specified in the text of the rule that appears below. 
This final rule should not have a significant impact on the healthcare 
industry because these nine fentanyl-related substances have no medical 
use and they have already been added as schedule I controlled 
substances since 2018.
    Comment: One commenter discussed the direct and indirect effects on 
federal and state healthcare from this regulation. The commenter 
suggested that this regulation will boost federal oversight of 
manufacturing and disseminating harmful chemicals. In addition, this 
regulation would limit availability and expected use, ensure protection 
of residents, and increases confidence in the medical field. In 
addition, the commenter stated that is critical to restrict the use of 
``fentanyl replicates'' to those who may need them for medical 
conditions. Lastly, the commenter stated that raising awareness of the 
risks of abusing these drugs benefits their prevention.
    DEA Response: DEA appreciates the comments in support of this 
rulemaking. As mentioned previously, FDA has not approved a marketing 
application for a drug product containing any of these nine substances 
for any therapeutic indication. These substances have no medical use in 
the United States.
    Comment: One commenter stated that this rule will affect federal 
healthcare because many federal agencies are trying to tackle the 
opioid crisis. The commenter discussed the rising number of pediatric 
deaths from fentanyl in 2021 and the surge in 2018 of fentanyl 
overdoses among older adolescents as well as in children younger than 
five. The commenter agrees with this final rule to schedule these 
fentanyl-related substances. The commenter also stated that fentanyl is 
highly addictive and that while fentanyl is prescribed for chronic pain 
or major surgery, it should be a last resort.
    DEA Response: DEA appreciates the comments in support of this 
rulemaking.
    Comment: One commenter agreed with this final rule to make 
permanent these nine specific fentanyl-related substances rather than 
continuing multiple temporary extensions. Once finalized, the commenter 
stated that the federal government could act against anyone handling 
these substances since over 150 people die each day from a fentanyl-
related drug overdose.
    DEA Response: DEA appreciates the comments in support of this 
rulemaking. Again, DEA notes that fentanyl is a schedule II controlled 
substance that can be prescribed for approved medical uses. However, 
the nine fentanyl-related substances addressed in this rule are already

[[Page 85106]]

schedule I controlled substances and none of them have any medical use 
in the United States.
    Comment: One commenter stated that fentanyl should be placed in 
schedule I. The commenter compared this substance to marijuana, which 
is a schedule I drug and thought it was mind-blowing that fentanyl was 
not a schedule I substance. It was suggested that the rising number of 
deaths, the risk to public health, abuse potential, and dependency 
should classify fentanyl as a schedule I.
    DEA Response: DEA appreciates this comment. As stated previously, 
fentanyl remains a schedule II substance. Fentanyl has approved medical 
uses in the United States. This final rule only applies to the 
fentanyl-related substances that are listed in this final order.

Scheduling Conclusion

    After consideration of the relevant matter presented through public 
comments, the scientific and medical evaluation and accompanying 
recommendation of HHS, and after its own eight-factor evaluation, DEA 
finds that these facts and all other relevant data constitute 
substantial evidence of the potential for abuse of meta-fluorofentanyl, 
meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl 
fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl fentanyl, ortho-
fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, and para-
methylcyclopropyl fentanyl. DEA is permanently scheduling these nine 
fentanyl-related substances as schedule I controlled substances under 
the CSA.

Determination of Appropriate Schedule

    The CSA establishes five schedules of controlled substances known 
as schedules I, II, III, IV, and V. The CSA also specifies the findings 
required to place a drug or other substance in any particular 
schedule.\3\ After consideration of the analysis and recommendation of 
the Assistant Secretary for HHS and review of all other available data, 
the Administrator, pursuant to 21 U.S.C. 811(a) and 812(b)(1), finds 
the following:
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    \3\ 21 U.S.C. 812(b).
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    (1) The abuse potential of meta-fluorofentanyl, meta-
fluoroisobutyryl fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl 
fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl fentanyl, ortho-
fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, and para-
methylcyclopropyl fentanyl is associated with each substance's 
pharmacological similarity to other schedule I and II mu-opioid 
receptor agonist substances which have a high potential for abuse. 
Similar to morphine (schedule II), fentanyl (schedule II), and several 
schedule I opioid substances that are structurally related to fentanyl, 
these nine fentanyl-related substances have been shown to bind and act 
as mu-opioid receptor agonists;
    (2) meta-Fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-
methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, 
isovaleryl fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl 
butyryl fentanyl, and para-methylcyclopropyl fentanyl, have no 
currently accepted medical use in treatment in the United States; \4\ 
and
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    \4\ Although there is no evidence suggesting that meta-
fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl 
fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl 
fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl butyryl 
fentanyl, and para-methylcyclopropyl fentanyl have a currently 
accepted medical use in treatment in the United States, it bears 
noting that a drug cannot be found to have such medical use unless 
DEA concludes that it satisfies a five-part test. Specifically, with 
respect to a drug that has not been approved by FDA, to have a 
currently accepted medical use in treatment in the United States, 
all of the following must be demonstrated:
    i. The drug's chemistry must be known and reproducible;
    ii. there must be adequate safety studies;
    iii. there must be adequate and well-controlled studies proving 
efficacy;
    iv. the drug must be accepted by qualified experts; and
    v. the scientific evidence must be widely available.
    57 FR 10499 (1992).
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    (3) There is a lack of accepted safety for use of meta-
fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl 
fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl 
fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, 
and para-methylcyclopropyl fentanyl under medical supervision.
    Based on these findings, the Administrator concludes that meta-
fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl 
fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl 
fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, 
and para-methylcyclopropyl fentanyl, including their isomers, esters, 
ethers, salts, and salts of isomers, esters, and ethers whenever the 
existence of such isomers, esters, ethers, and salts is possible, 
warrant control in schedule I of the CSA.\5\
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    \5\ 21 U.S.C. 812(b)(1).
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    This final rule does not affect the scheduling of fentanyl itself, 
which remains a schedule II controlled substance.

Requirements for Handling Meta-Fluorofentanyl, Meta-Fluoroisobutyryl 
Fentanyl, Para-Methoxyfuranyl Fentanyl, 3-Furanyl Fentanyl, 2',5'-
Dimethoxyfentanyl, Isovaleryl Fentanyl, Ortho-Fluorofuranyl Fentanyl, 
Alpha'-Methyl Butyryl Fentanyl, and Para-Methylcyclopropyl Fentanyl

    Meta-Fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-
methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, 
isovaleryl fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl 
butyryl fentanyl, and para-methylcyclopropyl fentanyl will continue, on 
a permanent basis,\6\ to be subject to the CSA's schedule I regulatory 
controls and administrative, civil, and criminal sanctions applicable 
to the manufacture, distribution, dispensing, importing, exporting, 
research, and conduct of instructional activities, including the 
following:
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    \6\ meta-fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-
methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-
dimethoxyfentanyl, isovaleryl fentanyl, ortho-fluorofuranyl 
fentanyl, alpha'-methyl butyryl fentanyl, and/or para-
methylcyclopropyl fentanyl have been subject to schedule I controls 
on a temporary basis, pursuant to 21 U.S.C. 811(h), by virtue of the 
February 6, 2018 temporary scheduling order (83 FR 5188) and the 
subsequent statutory extension of that order through December 31, 
2024 (Pub. L. 117-328, Division O, Title VI, Sec. 601).
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    1. Registration. Any person who handles (manufactures, distributes, 
dispenses, imports, exports, engages in research, or conducts 
instructional activities or chemical analysis with, or possesses) meta-
fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl 
fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl 
fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, 
and para-methylcyclopropyl fentanyl, or who desires to handle these 
nine substances, is required to be registered with DEA to conduct such 
activities pursuant to 21 U.S.C. 822, 823, 957, and 958, and in 
accordance with 21 CFR parts 1301 and 1312. Retail sales of schedule I 
controlled substances to the general public are not allowed under the 
CSA. Possession of any quantity of these substances in a manner not 
authorized by the CSA is unlawful and those in possession of any 
quantity of these substances may be subject to prosecution pursuant to 
the CSA.
    2. Disposal of stocks. meta-fluorofentanyl, meta-fluoroisobutyryl 
fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-

[[Page 85107]]

dimethoxyfentanyl, isovaleryl fentanyl, ortho-fluorofuranyl fentanyl, 
alpha'-methyl butyryl fentanyl, and para-methylcyclopropyl fentanyl 
must be disposed of in accordance with 21 CFR part 1317, in addition to 
all other applicable federal, state, local, and tribal laws.
    3. Security. meta-fluorofentanyl, meta-fluoroisobutyryl fentanyl, 
para-methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-
dimethoxyfentanyl, isovaleryl fentanyl, ortho-fluorofuranyl fentanyl, 
alpha'-methyl butyryl fentanyl, and para-methylcyclopropyl fentanyl are 
subject to schedule I security requirements and must be handled and 
stored pursuant to 21 U.S.C. 823, and in accordance with 21 CFR 
1301.71-1301.76. Non-practitioners handling these nine substances must 
also comply with the employee screening requirements of 21 CFR 1301.90-
1301.93.
    4. Labeling and Packaging. All labels and labeling for commercial 
containers of meta-fluorofentanyl, meta-fluoroisobutyryl fentanyl, 
para-methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-
dimethoxyfentanyl, isovaleryl fentanyl, ortho-fluorofuranyl fentanyl, 
alpha'-methyl butyryl fentanyl, and para-methylcyclopropyl fentanyl, 
must be in compliance with 21 U.S.C. 825, and be in accordance with 21 
CFR part 1302.
    5. Quota. Only registered manufacturers are permitted to 
manufacture meta-fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-
methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, 
isovaleryl fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl 
butyryl fentanyl, and para-methylcyclopropyl fentanyl in accordance 
with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 
21 CFR part 1303.
    6. Inventory. Any person registered with DEA to handle meta-
fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl 
fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl 
fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, 
and para-methylcyclopropyl fentanyl must have an initial inventory of 
all stocks of controlled substances (including these substances) on 
hand on the date the registrant first engages in the handling of 
controlled substances pursuant to 21 U.S.C. 827 and 958(e), and in 
accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
    After the initial inventory, every DEA registrant must take a new 
inventory of all stocks of controlled substances (including meta-
fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl 
fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl 
fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, 
and para-methylcyclopropyl fentanyl) on hand every two years pursuant 
to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR 1304.03, 
1304.04, and 1304.11.
    7. Records and Reports. Every DEA registrant must maintain records 
and submit reports with respect to meta-fluorofentanyl, meta-
fluoroisobutyryl fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl 
fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl fentanyl, ortho-
fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, and para-
methylcyclopropyl fentanyl, pursuant to 21 U.S.C. 827 and 958(e), and 
in accordance with 21 CFR parts 1301.74(b) and (c), 1301.76(b), 1307.11 
and parts 1304, 1312, and 1317. Manufacturers and distributors must 
submit reports regarding these substances to the Automation of Reports 
and Consolidated Order System pursuant to 21 U.S.C. 827 and in 
accordance with 21 CFR parts 1304 and 1312.
    8. Order Forms. Every DEA registrant who distributes meta-
fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl 
fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl 
fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, 
and para-methylcyclopropyl fentanyl must continue to comply with the 
order form requirements, pursuant to 21 U.S.C. 828 and in accordance 
with 21 CFR part 1305.
    9. Importation and Exportation. All importation and exportation of 
meta-fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-
methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, 
isovaleryl fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl 
butyryl fentanyl, and para-methylcyclopropyl fentanyl must comply with 
21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 
1312.
    10. Liability. Any activity involving meta-fluorofentanyl, meta-
fluoroisobutyryl fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl 
fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl fentanyl, ortho-
fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, and para-
methylcyclopropyl fentanyl not authorized by, or in violation of, the 
CSA or its implementing regulations is unlawful and may subject the 
person to administrative, civil, and/or criminal sanctions.

Regulatory Analyses

Executive Orders (E.O.) 12866 (Regulatory Planning and Review), 13563 
(Improving Regulation and Regulatory Review), and 14094 (Modernizing 
Regulatory Review)

    This action is not a significant regulatory action as defined by 
Executive Order (E.O.) 12866 (Regulatory Planning and Review), section 
3(f), and the principles reaffirmed in E.O. 13563 (Improving Regulation 
and Regulatory Review); and, accordingly, this action has not been 
reviewed by the Office of Management and Budget (OMB). This action 
makes no change in the status quo, as meta-fluorofentanyl, meta-
fluoroisobutyryl fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl 
fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl fentanyl, ortho-
fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, and para-
methylcyclopropyl fentanyl are already listed as a schedule I 
controlled substances.

Executive Order 12988, Civil Justice Reform

    This action meets the applicable standards set forth in sections 
3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors and 
ambiguity, minimize litigation, provide a clear legal standard for 
affected conduct, and promote simplification and burden reduction.

Executive Order 13132, Federalism

    This rulemaking does not have federalism implications warranting 
the application of E.O. 13132. The rule does not have substantial 
direct effects on the states, on the relationship between the National 
Government and the states, or the distribution of power and 
responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This rule does not have tribal implications warranting the 
application of E.O. 13175. It does not have substantial direct effects 
on one or more Indian tribes, on the relationship between the Federal 
Government and Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.

Regulatory Flexibility Act

    The Administrator, in accordance with the Regulatory Flexibility 
Act, 5 U.S.C. 601-602, has reviewed this final rule and, by approving 
it, certifies that it will not have a significant economic impact on a 
substantial number of small

[[Page 85108]]

entities. On February 6, 2018, DEA published an order to temporarily 
place fentanyl-related substances in schedule I of the CSA pursuant to 
the temporary scheduling provisions of 21 U.S.C. 811(h). DEA estimates 
that all entities handling or planning to handle meta-fluorofentanyl, 
meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl 
fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl fentanyl, ortho-
fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, and para-
methylcyclopropyl fentanyl have already established and implemented the 
systems and processes required to handle these substances.
    As discussed in the NPRM, there are 108 registrations authorized to 
handle one or more of the following substances: meta-fluorofentanyl, 
meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl 
fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl fentanyl, ortho-
fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, and para-
methylcyclopropyl fentanyl, as well as a number of registered 
analytical labs that are authorized to handle schedule I controlled 
substances generally. These 108 registrations represent a maximum of 95 
small entities. Therefore, DEA conservatively estimates as many as 95 
small entities are affected by this rule.
    A review of the 108 registrations indicates that all entities that 
currently handle meta-fluorofentanyl, meta-fluoroisobutyryl fentanyl, 
para-methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-
dimethoxyfentanyl, isovaleryl fentanyl, ortho-fluorofuranyl fentanyl, 
alpha'-methyl butyryl fentanyl, and para-methylcyclopropyl fentanyl, 
also handle other schedule I controlled substances and have established 
and implemented (or maintain) the systems and processes required to 
handle these substances. Therefore, DEA anticipates that this final 
rule will impose minimal or no economic impact on any affected 
entities, and, thus, will not have a significant economic impact on any 
of the small entities. Therefore, DEA has concluded that this final 
rule will not have a significant economic impact on a substantial 
number of small entities.

Unfunded Mandates Reform Act of 1995

    In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 
2 U.S.C. 1501 et seq., DEA has determined and certifies that this 
action would not result in any federal mandate that may result ``in the 
expenditure by State, local, and Tribal Governments, in the aggregate, 
or by the private sector, of $100 million or more (adjusted annually 
for inflation) in any 1 year * * * .'' Therefore, neither a Small 
Government Agency Plan nor any other action is required under UMRA of 
1995.

Paperwork Reduction Act of 1995

    This final rule does not impose a new collection or modify an 
existing collection of information under the Paperwork Reduction Act of 
1995. 44 U.S.C. 3501-3521. Also, this final rule does not impose new or 
modify existing recordkeeping or reporting requirements on State or 
local governments, individuals, businesses, or organizations. However, 
this final rule does require compliance with the following existing OMB 
collections: 1117-0003, 1117-0004, 1117-0006, 1117-0008, 1117-0009, 
1117-0010, 1117-0012, 1117-0014, 1117-0021, 1117-0023, 1117-0029, and 
1117-0056. An agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number.

Congressional Review Act

    This rule is not a major rule as defined by the Congressional 
Review Act (CRA), 5 U.S.C. 804. Pursuant to the CRA, DEA is submitting 
a copy of this final rule to both Houses of Congress and to the 
Comptroller General.

Determination To Make Rule Effective Immediately

    As indicated above, this rule finalizes the schedule I control 
status of nine substances that has already been in effect. These nine 
substances all fall within the definition of fentanyl-related 
substances set forth in the February 6, 2018, temporary scheduling 
order (83 FR 5188). Through the Temporary Reauthorization and Study of 
the Emergency Scheduling of Fentanyl Analogues Act, which became law on 
February 6, 2020, Congress extended the temporary control of fentanyl-
related substances until May 6, 2021. This temporary order was 
subsequently extended multiple times, most recently on December 29, 
2022, through the Consolidated Appropriations Act, 2023, which extended 
the order until December 31, 2024.\7\ The February 2018 order was 
effective on the date of publication, and was based on findings by the 
then-Acting Administrator that the temporary scheduling of the 
fentanyl-related substances was necessary to avoid an imminent hazard 
to the public safety pursuant to 21 U.S.C. 811(h)(1). Because this rule 
finalizes the control status of nine substances that has already been 
in effect, it does not alter the legal obligations of any person who 
handles these substances. Rather, it merely makes permanent the current 
scheduling status and corresponding legal obligations. Therefore, since 
this rule does not change the current scheduling status and 
corresponding legal obligations, DEA is making the rule effective on 
the date of publication in the Federal Register, as any delay in the 
effective date is unnecessary and would be contrary to the public 
interest.
---------------------------------------------------------------------------

    \7\ Public Law 117-328, Division O, Title VI, Sec. 601.
---------------------------------------------------------------------------

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
November 29, 2023, by Administrator Anne Milgram. That document with 
the original signature and date is maintained by DEA. For 
administrative purposes only, and in compliance with requirements of 
the Office of the Federal Register, the undersigned DEA Federal 
Register Liaison Officer has been authorized to sign and submit the 
document in electronic format for publication, as an official document 
of DEA. This administrative process in no way alters the legal effect 
of this document upon publication in the Federal Register.

Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Reporting and recordkeeping requirements.

    For the reasons set out above, 21 CFR part 1308 is amended as 
follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for 21 CFR part 1308 continues to read as 
follows:

    Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise 
noted.


0
2. In Sec.  1308.11:
0
a. Redesignate paragraphs (b)(10) through (94) to read as follows:

------------------------------------------------------------------------
               Old paragraph                        New paragraph
------------------------------------------------------------------------
(b)(10) through (33)......................  (b)(11) through (34).
(b)(34) through (43)......................  (b)(36) through (45).
(b)(44) through (47)......................  (b)(47) through (50).
(b)(48) through (50)......................  (b)(52) through (54).
(b)(51) through (66)......................  (b)(57) through (72).
(b)(67) through (74)......................  (b)(74) through (81).
(b)(75) through (94)......................  (b)(84) through (103).
------------------------------------------------------------------------

0
b. Add new paragraphs (b)(10), (35), (46), (51), (55), (56), (73), 
(82), and (83);
    The additions to read as follows:

[[Page 85109]]

Sec.  1308.11  Schedule I.

* * * * *
    (b) * * *

 
                              * * * * * * *
(10) alpha'-Methyl butyryl fentanyl (2-methyl-N-(1-                 9864
 phenethylpiperidin-4-yl)-N-phenylbutanamide)....................
 
                              * * * * * * *
(35) 2',5'-Dimethoxyfentanyl (N-(1-(2,5-                            9861
 dimethoxyphenethyl)piperidin-4-yl)-N-phenylpropionamide)........
 
                              * * * * * * *
(46) 3-Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-           9860
 phenylfuran-3-carboxamide)......................................
 
                              * * * * * * *
(51) Isovaleryl fentanyl (3-methyl-N-(1-phenethylpiperidin-4-yl)-   9862
 N-phenylbutanamide).............................................
 
                              * * * * * * *
(55) meta-Fluorofentanyl (N-(3-fluorophenyl)-N-(1-                  9857
 phenethylpiperidin-4-yl)propionamide)...........................
(56) meta-Fluoroisobutyryl fentanyl (N-(3-fluorophenyl)-N-(1-       9858
 phenethylpiperidin-4-yl)isobutyramide)..........................
 
                              * * * * * * *
(73) ortho-Fluorofuranyl fentanyl (N-(2-fluorophenyl)-N-(1-         9863
 phenethylpiperidin-4-yl)furan-2-carboxamide)....................
 
                              * * * * * * *
(82) para-Methoxyfuranyl fentanyl (N-(4-methoxyphenyl)-N-(1-        9859
 phenethylpiperidin-4-yl)furan-2-carboxamide.....................
(83) para-Methylcyclopropyl fentanyl (N-(4-methylphenyl)-N-(1-      9865
 phenethylpiperidin-4-yl)cyclopropanecarboxamide)................
 

* * * * *
[FR Doc. 2023-26694 Filed 12-6-23; 8:45 am]
BILLING CODE 4410-09-P